FDA.reportPublic FDA data

MAUDE MDR 9831298

MDR report key
9831298
Report number
9611109-2020-00181
Event key
0
Event type
3
Date of event
2020-02-12
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ENRICO GRECO
Address
14401 W. 65TH WAY ARVADA CO 80004 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEATER-COOLER SYSTEM 3TCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASSLIVANOVA DEUTSCHLAND GMBHDWC16-02-85* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

No narrative records found.